EDITORIAL: Door opens for trial

While the ordinance has paved the way for importing vaccines for trial, the govt must ensure that they are affordable

With the issuance of an ordinance by President Bidhya Devi Bhandari on Wednesday to make the third amendment to the Drugs Act-1978, the door has been opened for launching clinical trials of drugs or vaccines against coronavirus in the country. Many drugs or vaccines are under clinical trial in several countries, and some of them have shown encouraging results when they were tested in select groups of people. Pfizer and its German partner BioNTech and Moderna Inc claim that their experimental vaccines are 95 and 94.5 per cent effective respectively with minimal side effects to the recipients. These vaccines and others developed in Russia and China are under clinical trial, and they can be imported to Nepal legally by authorised drug firms now that the ordinance has come into force. Before the issuance of the ordinance, prior approval was necessary from the Department of Drugs Management under the Drugs Act-1978. Under the new provision, a new vaccine can also be launched for clinical trial, and such a vaccine can also be administered in Nepal by taking permission from the concerned regulatory body.

A vaccine, which is under clinical trial as per the permission of the regulatory body of a foreign country, can also be launched for clinical trial in Nepal as well if the firm or company that developed such a vaccine wishes so, the ordinance says. However, a drug or vaccine, which is still in the phase of clinical trial, should be administered to the people only after taking their informed consent. Prior to this, there was no such provision in the Act. That is why drug companies in Nepal had been reluctant to import Ramdesivir, a drug that is administered to patients hospitalised with COVID-19, citing legal complications, and the affected people were forced to purchase it in the black market.

With the amendment to the Act, Nepal can also propose drug companies or countries to conduct the clinical trial of their drugs or vaccine within the country. Public health experts believe that this provision will make it easier to bring the much-needed medicine in the country should the clinical trial becomes a success. Besides, import of drugs or vaccines needed for the treatment of COVID-19 patients has also been made easier. The ordinance has clearly stated that a drug or vaccine, which has been permitted by other countries or recommended by WHO for emergency use, can be imported in Nepal without any hassles. Those drugs or vaccines can be prevented from using them at the community level if they are restricted by the concerned countries or WHO, citing health complications on the recipients. Although the ordinance has paved the way for importing such drugs or vaccines in the country, the government must make sure that they are affordable. Nobody should be allowed to mint money taking advantage of the dire situation. The drug companies or the countries that produce the anti-virus vaccines or drugs should be ready to provide them to Nepal at the lowest cost for allowing them to launch the clinical trial of their drugs here. Nepal should also be the first among the countries to receive them for giving permission for their trial.

What a paradox

At a time when critical COVID-19 patients are unable to avail themselves of ventilator services in hospitals, the equipment is lying idle in different health facilities of far west Nepal. The ventilators were bought by the Sudurpaschim Province Government months ago to treat coronavirus patients, but they have not been put to use for lack of necessary manpower to handle them. This is a colossal wastage of scarce resources that have gone into purchasing the ventilators for different hospitals in the province.

Nepal’s hospitals are said to have only about 900 ventilators necessary for patients with breathing problems, with more than half of them concentrated in the capital. Hence, with the rising number of corona cases in the country, every ventilator counts.

However, what good are these life-saving machines if there are no experts to operate them? For reasons such as these, Nepal is simply not prepared for a pandemic. Unfortunately, there has been a spike in the number of corona cases in the country in recent weeks, and they are expected to jump with the onset of winter. So it would be in the interest of everyone to keep the ventilators ready and running as early as possible.

The post EDITORIAL: Door opens for trial appeared first on The Himalayan Times.